CONCORDE LIFT 1978-11-021CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034531540), received between Apr 4, 2019 and Apr 4, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Collapse” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K171425); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2019Collapse; Collapse

  IT WAS REPORTED THAT DR (B)(6) SENT ME AN IMAGE OF A PATIENT AT ONE MONTH POST OP, AND THREE MONTHS POST OP. THE CONCORDE LIFT CAGE HEIGHT APPEARS TO HAVE CHANGED FROM ONE MONTH TO THREE MONTHS. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? YES, IF YES, PLEASE DESCRIBE. THE CONCORDE LIFT CAGE HEIGHT APPEARS TO HAVE CHANGED FROM ONE MONTH TO THREE MONTHS. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? NO, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? NONE, PATIENT STATUS/ OUTCOME/CONSEQUENCES? NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, IP-00528400: DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? PATIENT. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AV

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8484141 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171425. One submission often covers many models, so check the product and lot details in each record.

• Z-1225-2019 · Apr 8, 2019 · Terminated
  Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (U
• Z-0848-2018 · Jul 26, 2017 · Terminated
  Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.